Senior PV Quality Manager, GVP Quality
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Job Location:
Gentofte Kommune - Denmark
Monthly Salary:
DKK 5 - 10
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Are you passionate about GVP audits Do you have a strong quality mindset
If so now is your chance to join Ascendis Pharma as our new Senior PV Quality Manager.
Ascendis Pharma is a global biopharmaceutical company committed to making a meaningful difference in patients lives. Guided by our core values of Patients Science and Passion we are applying our innovative TransCon technology platform to fulfill our mission of developing new therapies that demonstrate best-in-class potential to address unmet medical needs.
At our headquarters in Hellerup Denmark research facilities in Heidelberg Germany and additional offices across Europe and the United States we are advancing programs in our Endocrinology Rare Disease and Oncology portfolios. We also collaborate with partners on the development of TransCon-based products in other therapeutic areas and markets.
Ascendis Pharma is currently expanding its GVP Quality with a GVP auditor position.
Join the GVP Quality team in a fast-growing Pharma company with a strong pipeline
- Exiting opportunity in a global team headquartered in Hellerup DK
- Interesting and important cross functional collaborations
- You join a well-functioning group where you play an important role with your personality and competences
- You are positive see opportunities and get things done
In GVP Quality you will together with a growing & dynamic quality team take part in the oversight of the compliance quality standards GVP auditing and training for Pharmacovigilance. The GVP Quality team is a part of the QA Development team with around 35 dedicated colleagues located in Hellerup Denmark and Palo Alto USA respectively. This role is based in Hellerup Denmark and reports directly to the Director GVP Quality based in Denmark.
Main areas of responsibility:
- Plan perform and report on GVP audits (internal affiliate and vendor/partner) in collaboration with GVP colleagues.
- Review and analyze audit inspection deviation and CAPA data to identify root causes trends and areas of exposure.
- Prepare compliance metrics conduct non-compliance investigations and support regulatory inspections including planning execution and follow-up.
- Provide expert advice on GVP compliance and regulatory matters acting as quality partner to PV Operations (US/DK) and the EU QPPV.
- Author and maintain GVP Quality procedures and support implementation of new or updated GVP requirements.
- Support PV vendor oversight including quality agreements and contracts and proactively monitor PV Quality systems to identify risks.
- Collaborate with SMEs on inspection responses and quality development initiatives within the GVP area.
Criteria for success in the role will be proven ability to make and take responsibility for decisions to meet the ever growing and changing stringent global GVP requirements. Furthermore a strong quality mindset and attention to detail in establishing priorities scheduling and meeting deadlines is essential.
You hold a masters degree in a scientific discipline and have minimum 5 -10 years of experience in the pharmaceutical industry with significant experience in GVP. You have experience as a GVP auditor and experience in quality systems compliance monitoring and the development and maintenance of SOPs and training programs. Experience with auditing computerized systems within the GPV regulated areas and medical device experience would be an advantage.
You are proficient in English at a professional level both written and spoken and you master MS Office.
You are a highly motivated individual who enjoys being challenged and working in collaborative environments. You value inter-departmental team relationships using your excellent interpersonal communication analytical and organizational skills.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharmas strategy and work with highly skilled and experienced colleagues to advance our exciting product pipeline.
Travelling: Approximately 20-30 days on a yearly basis.
Place of work: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view to the harbor the canals and the sea.
For more details about the job or the company please contact Helle Virenfeldt Sall Director GVP Qualityon Mobile 45 or All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received so please apply as soon as possible.
A note torecruiters:
Wedo notallowexternalsearchparty ofcandidateswithoutwrittenpermission from the Ascendis PharmaHR team(specificallyfrom: TalentAcquisitionPartner or Human ResourcesDirector) is .
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Founded in Copenhagen, Denmark in 2007, Ascendis Pharma is a publicly held, biopharmaceutical company committed to addressing unmet medical needs. Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a ... View more
